The Clinical Trial Master File Essentials

The Trial Master File (TMF) is one of the most common areas for critical and major inspection findings.This online course covers the key requirements of the TMF.
It is suitable for all those involved with clinical trials who are generating and maintaining trial documents.

The course is based on known inspection findings and the European Medicines Agency guideline on the Trial Master File and takes around 1-hour to complete
It has both read-only and narrated tracks.

The course is packed with interactions to maintain interest and to enhance the learning experience.
It is based on a series of questions that may be posed by an inspector or auditor and this forms the basis of a ‘health-check’ for those working with trial documents.

Topics include:

• Inspection metrics and critical TMF issues.
• ICH basics relating to TMF.
• Definition of the TMF and its content, the TMF index.
• TMF and trial reconstruction.
• Documents common to several trials.
• Segregation: sponsor, vendor and investigator documents.
• Drafts and superseded documents.
• Dealing with correspondence and emails.
• Scanning and certified copies.
• Destruction of trial documents.
• Vendors and CRO involvement in the TMF.
• Access and security.
• Retention and archiving.
• Quality management , QC, TMF oversight.
• Impact of the pandemic on TMF.
• Filing rules and inspection readiness.

Like our other online training courses, this course can be customized with client branding and logo.

The course can be managed by Brookwood (registration, invitations, tracking, reporting and certification) or it can be provided as a Scorm file for delivery under license using a Client’s own LMS.

For details of packages for training larger groups contact us at info@brookwood-global.com